Monograph Details
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Infections & Infestations
> Viral infections
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COPEGUS |
| Manufacturer |
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Roche Laboratories |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Nucleoside analogue. |
| Generic Name |
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Ribavirin 200mg; tabs. |
| Indications |
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Chronic hepatitis C, in combination with peginterferon alfa-2a (Pegasys), in patients with compensated liver disease previously untreated with alpha interferon, including patients co-infected with HIV. |
| Children |
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≤18yrs: not recommended. |
| Adults |
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Take with food in 2 divided doses. ≥18yrs: Genotype 1, 4: (<75kg): 1g/day for 48 weeks; (≥75kg): 1.2g/day for 48 weeks. Genotype 2, 3: 800mg/day for 24 weeks. HIV patients: 800mg/day for 48 weeks. Reduce dose or discontinue if severe reactions or hematologic abnormalities occur. Cardiac disease: discontinue if cardiovascular status deteriorates; reduce dose or discontinue if hemoglobin levels decrease; see literature. Renal impairment (CrCl<50mL/min): not recommended. |
| Contraindications |
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Autoimmune hepatitis. Significant or unstable cardiac disease, hemoglobinopathies (eg, thalassemia, sickle-cell anemia): not recommended. Renal dysfunction (CrCl <50mL/min). Hepatic decompensation before or during therapy. Male partners of pregnant women. Pregnancy (Cat. X). |
| Precautions |
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Women of childbearing potential: obtain negative pregnancy test immediately before starting therapy. Women of childbearing potential and men: use 2 forms of effective contraception during and for 6 months following treatment. Do baseline CBC (and at weeks 2 and 4 or more often if needed), white counts with differential, platelet counts, blood chemistry, thyroid, and monthly pregnancy tests (during and for 6 months after treatment). Suspend or discontinue if cardiovascular status deteriorates. Psychiatric disorders. Autoimmune disorders. Organ transplant. Pancreatitis. Decompensated hepatitis C. Nonresponders to interferon. Co-infection with hepatitis B virus. Maintain adequate hydration. Nursing mothers: not recommended. |
| Interactions |
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Avoid alcohol. May antagonize stavudine, zidovudine. Caution with NRTIs; monitor for toxicities. Concomitant didanosine: not recommended. |
| Adverse Reactions |
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Anemia and other hematological disorders, flu-like symptoms, cardiac events, pulmonary events, psychiatric effects, dizziness, GI upset, weight loss, alopecia, rash, pruritus, diabetes, pancreatitis. |
| Extra Text |
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Note: Register pregnant women exposed to Copegus by calling (800) 593-2214 (see Contraindications). |
| How Supplied |
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Tabs—168 |
| Additional Resources |
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• Related Prescribing Note |
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